Aim of the study:

The presence of severe calcification of the aortic valve poses a special challenge in patients undergoing transcatheter aortic valve replacement (TAVR). Only a few studies have addressed the performance of transcatheter heart valves (THV) in this particular subset of patients. We aimed to determine the performance of the self-expanding Evolut valve frame (Evolut R and Evolut Pro, Medtronic, Minneapolis, MN) and balloon-expandable Sapien-3 valve family (Edwards Lifesciences, Irvine, CA) regarding in-hospital outcomes in this challenging patient subpopulation.

Materials and methods: 

We performed a database search for all patients with severe aortic stenosis, who underwent TAVR at five high volume heart centers in Germany between 07.2013 and 01.2021. We identified 1516 patients with highly calcific aortic valve annulus, defined as a calcium score of more than 700 mm³ using 3Mensio software (Pie Medical Imaging) or Agatston score above 3000 HU. Primary endpoint was the incidence of paravalvular leak (PVL) after TAVR. Secondary endpoints were pressure gradient across the THV and THV area in addition to clinical endpoints according to the VARC-3 definition.

Results: 

in our cohort, 783 patients received Sapien-3, 499 patients received Evolut R and 231 patients received Evolut PRO, while in 3 patients the type of the valve was not documented.

Evolut R showed a significantly higher rates of PVLs compared to Sapien-3 (44.6% vs 29.5% for mild PVL, 12.3% vs 11.5% for moderate PVL and 1.8% vs 0.2% for sever PLV, p=<0.001; respectively). However, there was no significant difference in the incidence of PVL between the Evolut PRO and Sapien-3 groups (34.4% vs 29.5% for mild PVL, 14.1% vs 11.5% for moderate PVL and 1% vs 0.2% for sever PLV, p=0.124; respectively).

Post-implant hemodynamics and THV area are presented in table 1.

Table 1: Values are presented as median (interquartile range). MPG=mean pressure gradient; PPG=peak pressure gradient; THV=transcatheter heart valve.

Sapien-3 showed significantly higher rates of pericardial tamponade when compared to Evolut R (1.4% vs 0%, p=0.024, respectively) and significantly higher rates of acute kidney injury when compared to Evolut PRO (8.3% vs 3.9%, p=0.021, respectively). Otherwise, the incidence of permanent pacemaker implantation did not differ significantly between the 3 groups (13.4% for Sapien-3, 16.4% for Evolut R and 14.8% for Evolut PRO, p=0.155). Similarly, all-cause mortality, cardiovascular mortality, disabling stroke, myocardial infarction, bleeding, major access site complications, and conversion to open surgery were comparable between the different groups. 

Conclusion:

In patients with a severely calcified aortic valve annulus undergoing TAVR, the incidence of PVL was higher in the Evolut R group in comparison to Sapien-3 group, however, Sapien-3 and Evolut PRO did not show any difference regarding the incidence of PVL. Both Evolut R and Evolut PRO showed better post-implant hemodynamics with lower mean and peak pressure gradients and larger THV area compared to the Sapien-3 group.